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An Investigational Drug, Crizotinib (PF-02341066), Is Being Studied In Tumors, Except Non-Small Cell Lung Cancer, That Are Positive For Anaplastic Lymphoma Kinase (ALK)

This study is currently recruiting participants.
Verified May 2013 by Pfizer
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01121588
First received: May 10, 2010
Last updated: May 3, 2013
Last verified: May 2013
History of Changes
  Purpose

This is a Phase 1 trial evaluating the safety and efficacy of crizotinib in patients with tumors except non-small cell lung cancer that are positive for ALK.


Condition Intervention Phase
Neoplasms Malignant
 Drug: Crizotinib
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 1B Open-Label Study Of The Safety And Clinical Activity Of Crizotinib (PF-02341066) In Tumors With Genetic Events Involving The Anaplastic Lymphoma (ALK) Gene Locus

Resource links provided by NLM:

Drug Information available for: Crizotinib
U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs);Type, incidence, severity, seriousness and relationship to study medication of adverse events and any laboratory abnormalities [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]
  • Objective Response Rate [ Time Frame: 36 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression-Free Survival (PFS) [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]
  • Overall survival [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]
  • Duration or Response [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • Plasma concentrations of crizotinib [ Time Frame: 30 months ] [ Designated as safety issue: No ]
  • Proportion of patients with each of the ALK genetic events [ Time Frame: 30 months ] [ Designated as safety issue: No ]
  • Phosphorylation status of ALK in the tumor samples from surgery or biopsy pre and post treatment when evaluable [ Time Frame: 36 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: March 2011
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Crizotinib Drug: Crizotinib
Crizotinib tablets, 250 mg BID, will be administered orally on a continuous dosing schedule
Other Name: PF-02341066

  Eligibility

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • histologically or cytologically proven diagnosis of malignancy other than NSCLC
  • positive for translocation or inversion event involving the ALK gene locus
  • positive for ALK amplification events
  • positive for ALK activating point mutations

Exclusion Criteria:

  • mutations of amplifications involving the c-Met gene but not the ALK gene
  • concurrent treatment on another therapeutic clinical trial
  • prior therapy specifically directed against ALK
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01121588

Contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021
Contact: Pfizer Oncology Clinical Trial Information Service 1-877-369-9753 PfizerCancerTrials@emergingmed.com

  Show 29 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01121588     History of Changes
Other Study ID Numbers: A8081013, PROFILE 1013
Study First Received: May 10, 2010
Last Updated: May 3, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
neoplasm malignant
lymphoma
neuroblastoma
 Crizotinib
anaplastic lymphoma kinase
ALK

Additional relevant MeSH terms:
Neoplasms
Carcinoma, Non-Small-Cell Lung
Lymphoma
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
 Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on May 19, 2013